Summary: Researchers at the University of Miami MS Center and are enrolling 158 people with MS-related cognitive problems for a placebo-controlled study to determine the potential benefits of a Medical Food on cognitive impairment in people with MS. The National MS Society through Fast Forward has partnered with Accera, Inc., to supply clinical trial material, and with the University of Miami’s Miller School of Medicine to provide funding for this trial.
Rationale: The Medical Food being studied is manufactured with foods or ingredients that have Generally Recognized as Safe (GRAS) status. The Medical Food has been previously studied in patients with mild to moderate Alzheimer’s disease, and is used for the clinical dietary management of the metabolic processes associated with mild to moderate Alzheimer’s disease.
Cognitive problems are a common symptom in individuals with MS and may have a negative impact on relationships, work, and quality of life. Treatment options are limited. Glucose (a type of sugar) is used to fuel the cells of the healthy brain. For people with neurological conditions such as MS, glucose may not be converted into energy as efficiently as it would be in a healthy brain, which can lead to a decrease in cognitive function. The Medical Food being studied may work to bypass this problem by providing an alternative energy source that is processed in the liver and used by the brain.
Eligibility and Details: People with all types of MS who are experiencing problems with memory or other aspects of cognition are eligible to participate. Participants should not have had a relapse or a medication change in the 30 days before study entry. More details about the enrollment criteria are available from the contact below.
Participants are being randomly assigned to receive the Medical Food once a day, orally, or inactive placebo, for 90 days. Participants will undergo detailed cognitive assessment before beginning the study and again after treatment.
The primary outcomes being measured are changes in clinical tests of verbal learning, memory, processing speed, and attention, as well as adverse events. The trial will also track secondary outcomes including changes in disability, depression, quality of life and fatigue.
Contact: To learn more about the enrollment criteria for this study, and to find out if you are eligible to participate, please contact the research Coordinator, Gloria Rodriguez at 305-243-8052 or by email at G.firstname.lastname@example.org.
Download a brochure that discusses issues to think about when considering enrolling in an MS clinical trial (PDF).
Without participants in research studies, MS research would come to a standstill. Read more here.